MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG BIOMONITOR III; IMPLANTABLE CARDIAC MONITOR

Model Number	436066
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Biotronik submits this report to comply with fda regulations 21 cfr parts 4 and 803.Biotronik has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by biotronik, or its employees that the device, biotronik, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Biotronik will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Loop was explanted due to loss of capture.No adverse patient events were reported.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
The device was received for analysis.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this device were reviewed and all production steps were performed accordingly.In particular, the final acceptance test proved the device functions to be as specified.A visual inspection of the device revealed no anomalies.The memory content of the device was inspected, showing a normal device function while implanted and in service.At a next step the device was subjected to an electrical analysis.A sensing test was performed and the device sensed the attached heart signals free of noise, proving the sensing functions to be as specified.In summary, the analysis revealed no indication of a device malfunction.

• Brand Name: BIOMONITOR III
• Common Device Name: IMPLANTABLE CARDIAC MONITOR
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 24634292
• Report Number: 1028232-2026-01362
• Device Sequence Number: 8596110
• Product Code: MXD
• UDI-Device Identifier: 04035479158453
• UDI-Public: (01)04035479158453(17)220228
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 436066
• Device Catalogue Number: 436066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male